510(k) K881449
- Device
- Edwards-duromedics Leaflet Probe, Model 1116
- Applicant
- BAXTER HEALTHCARE CORP.
- 510(k) number
- K881449
- Product code
- LXN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-06-15
- Date received
- 1988-04-05
- Regulation
- 870.4500
- Classification name
- Probe, Test, Heart-Valve
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN L ELY
- Address
- P O Box 11150 Santa Ana CA US 92711 92711
FDA Registration Numbers#
- 8044098
- 3012185136
- 1063481
- 3004478276
- 3003477135
- 3031231776
- 2029275
- 1058726
- 1649833
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LXN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K890165 | FORCEPS-ORTHOPEDIC | Dhason Brothers, Inc. | 1989-02-13 |